19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780767·LEVAMED ACTIVE ANKLE SUP SLVR L IV
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890122240·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040005989·Sterilization Tubing Cont Clr
GLACIER
FDA UDI
SDI LIMITED·DO3670122241·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112240·Tap, 6.50mm, Cannulated, Fixed Sleeve
PediPlate
FDA UDI
ORTHOPEDIATRICS CORP.·00841132109076·O-PLATE 24mm
NPAC MULTI-USE THERMOMETER, MODEL TD400
FDA 510(k)
FDA Class 2
·General Hospital
XPS 3000 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. 8010379·Product code JDI·March 20, 2013
3F X 60CM SINGLE VASCU-PICC
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·February 2, 2011
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
FDA Enforcement
Class II
·Terminated·Maytex Corp·June 12, 2013
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018